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DOBI Medical Systems Conducting Clinical Testing At Hackensack University Medical Center.


Business/Health Editors

MAHWAH, N.J.--(BUSINESS WIRE)--March 15, 2000

Mahwah, New Jersey Mahwah is a township in Bergen County, New Jersey, United States. As of the United States 2000 Census, the township population was 24,062. The name Mahwah is derived from the Lenni Lenape word "mawewi" which means "Meeting Place" or "Place Where Paths Meet".  based DOBI DOBI Division of Banking and Insurance  Medical Systems announced today that it has recently begun clinical testing of its patented Dynamic Optical Breast Imaging (DOBI) system at Hackensack University Medical Center Hackensack University Medical Center (HUMC) is a 781-bed non-profit, research and teaching hospital located just seven miles west of New York City, in Hackensack, New Jersey, providing tertiary and healthcare needs for northern New Jersey and the New York metropolitan area. , the largest provider of inpatient and outpatient services outpatient services Hospital-based services Managed care Medical and other services provided, to a nonadmitted Pt, by a hospital or other qualified facility–eg, mental health clinic, rural health clinic, mobile X-ray unit, free-standing dialysis unit Examples  in New Jersey. The Principal Investigator for the clinical study effort is Richard Davies, M.D., Chairman of the Department of Surgery and Professor of Surgery at University of Medicine and Dentistry - New Jersey Medical School. The clinical study effort is designed to evaluate the effectiveness of the DOBI system in differentiating cancer from benign lesions in women with equivocal mammograms and other clinical testing.

DOBI Medical's breast imaging system is based on the use of dynamic functional imaging to detect the development of blood vessels (angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization.

an·gi·o·gen·e·sis
n.
) associated with the growth of malignant lesions. The DOBI system is currently undergoing similar clinical tests in other U.S. hospitals including Massachusetts General in Boston and Columbia Presbyterian in New York. Earlier clinical testing has been conducted in Swansea, Wales Wales, Welsh Cymru, western peninsula and political division (principality) of Great Britain (1991 pop. 2,798,200), 8,016 sq mi (20,761 sq km), west of England; politically united with England since 1536. The capital is Cardiff.  along with additional product development testing at the National Surgery Center in Moscow, Russia.

The DOBI system is a unique and proprietary technology for digitized, optical imaging of the human body. In its initial application, the system is designed to offer a low-cost, non-invasive and pain free method to distinguish between cancer and benign lesions in a woman's breast.

DOBI Medical Systems anticipates their new technology will initially be used in an adjunctive role to mammography mammography, diagnostic procedure that uses low-dose X rays to detect abnormalities in the breasts. The early diagnosis of breast cancer made possible by the routine use of mammography for screening women increases a woman's treatment alternatives and improves her , with the objective of substantially reducing the large number of invasive surgical breast biopsies performed each day that turn out to be benign. In addition to the effects of biopsy as a surgical procedure, 8 out of 10 such biopsies are found to be benign. The financial cost of these biopsies is estimated to be over $8 billion annually worldwide.

The DOBI technology is protected by an intellectual property portfolio of seven domestic and international issued patents and a series of trademark approvals, with additional patents in development. The Company plans to begin formal clinical trials later this year and complete clinical testing of the DOBI system within 18 months. Results of this testing will be submitted to obtain FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval to begin marketing the product.

DOBI Medical Systems is a privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 involved with the development and deployment of optical imaging systems for use in the enhancement of medical screening, diagnosis, and monitoring of patients. It plans to seek FDA approval for the use of its Dynamic Optical Breast Imaging system as an adjunctive test to mammography and clinical evaluation for the detection of breast cancer. Sometimes referred to as an "optical biopsy", the DOBI system is designed to use near infrared light to accurately detect the angiogenesis often associated with cancer development. DOBI is a non-invasive, pain free test that takes less than 10 minutes to complete.

The Company has been provided financial support from private investors and West Palm Beach, Florida West Palm Beach, also known as West Palm, is the most populous city in Palm Beach County, Florida, USA. The city is also the oldest incorporated municipality in South Florida. According to the University of Florida's 2006 estimates, the city had a population of 107,617.  based Lake Worth Ventures. Lake Worth Ventures is a successful privately held venture capital firm that invests in health care and Internet-related companies that target technology based high growth markets.

Note to Editors: Additional information is contained on the attached DOBI Medical Fact Sheet, as well as on the company's web site, www.dobimedical.com.
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Publication:Business Wire
Date:Mar 15, 2000
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